BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM – GENTAMICIN 0.25 – 16 UG/ML


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K023273
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM – GENTAMICIN 0.25 – 16 UG/ML
Original Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

Original Contact kathryn babka powers
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 10/01/2002
Decision Date 10/31/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls